FDA Registration
Active
🇺🇸 United States
Monebo Automatic Arrhythmia Detection Software Library
Reg #: 3030254141
·
FEI: 3030254141
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CORVITALS
- Registration Number
- 3030254141
- FEI Number
- 3030254141
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 337 North Main St, Suite #11
- City
- New City
- State
- NY
- ZIP
- 10956
- Country
- US
Regulatory Submissions
- 510(k) Number
- K043380
Owner / Operator
- Firm Name
- CorVitals
- Operator Number
- 10089703
- Address
- 337 North Main St, Suite #11
- City
- New City
- State
- NY
- Postal Code
- 10956
- Country
- US
- Correspondent
- John Both
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2024-01-09 |
Proprietary Names
Monebo Automatic Arrhythmia Detection Software Library
Establishment Types
Complaint File Establishment per 21 CFR 820.198